Nebulizer

ABSTRACT

A nebulizer having an insertable container and a monitoring device for counting actuations of the nebulizer is proposed. The monitoring device is mounted in a detachable housing part and directly detects movements of container during a nebulizing process, an air supply current in the region of a mouthpiece, and/or the production of aerosol, in order to detect this as the actual dispensing of fluid and actuation of the nebulizer, while preferably the time of actuation of the nebulizer is additionally detected and stored. This allows better monitoring and guidance for the user.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to a nebulizer according to the preambleof claim 1.

2. Description of the Prior Art

The starting point for the present invention is a nebulizer in the formof an inhaler, as shown, in principle, in WO 91/14468 and specificallyin FIGS. 6a and 6b in WO 97/12687, and in FIGS. 1 and 2 of the presentapplication. The nebulizer comprises, as a reservoir for a fluid that isto be nebulized, an insertable container with the fluid and a pressuregenerator with a drive spring for conveying and atomizing the fluid. Byrotating an actuating member in the form of a lower housing part of thenebulizer the drive spring can be put under tension and fluid can bedrawn up into a pressure chamber of the pressure generator. After manualactuation of a locking element, the fluid in the pressure chamber is putunder pressure by the drive spring and nebulized, i.e., expelled to forman aerosol. During the tensioning process, on the one hand, andsubsequent atomizing, on the other hand, the container performs alifting movement. The nebulizer comprises a mechanical monitoring devicethat detects the rotation of the actuating member in order to count theactuations of the nebulizer. The known nebulizer operates exclusivelymechanically, i.e., without propellant gas and without electricity. WO91/14468 and WO 97/12687 are hereby incorporated by reference in theirentireties. Generally, the disclosures thereof refer to a nebulizerhaving a spring pressure of 5 to 60 MPa, preferably 10 to 50 Mpa, on thefluid with volumes per actuation of 10 to 50 μl, preferably 10 to 20 μl,most preferably about 15 μl, per actuation and particle sizes of up to20 μm, preferably 3 to 10 μm. Moreover, the disclosures thereinpreferably relate to a nebulizer with a cylinder-like shape that isabout 9 cm to about 15 cm long and about 2 to about 5 cm wide and anozzle spray spread of from 20° to 160°, preferably from 80° to 100°.These magnitudes also apply to the nebulizer according to the teachingof the invention as particularly preferred values.

A device is also known for detecting the actuation of a dispenser,wherein an expulsion conveyor is actuated by a lifting movement betweenan actuating member and a media container and in the actuating member isarranged a switch for detecting an actuation and producing an electricalcounting signal (DE 100 65 160). During the linear lifting movement, theswitch is not actuated directly by the container, but by a fixing screwof the device, so that, even when the container is not inserted, acounting signal is generated on each actuation.

DE 100 61 723 discloses a mechanical counter for counting meteredreleases of products in the form of liquids, pastes, or solids,particularly medicaments, from a supply container, particularly anaerosol container. Preferably, linear movement of the aerosol iscounted.

Also known is a dispensing control for a media dispenser (DE 198 07 921A1). This control comprises a store and an intermittent circuit thatallows possible actuation only at certain times and blocks it at othertimes. The store can be programmed using a computer so that the barrieris only opened at certain times, for which purpose a program comprises atime switch component. A display tells the user when a dose is to beadministered and when it is not. The store can detect theadministration, after which it can be displayed on a screen using acomputer at any time. In order to program and interrogate the memory orto charge up an energy store, the control may have an electricalconnection for a suitable plug that is accessible from outside.

SUMMARY OF THE INVENTION

The aim of the present invention is to provide a nebulizer of the kinddescribed above having an improved monitoring device, particularlyallowing improved safety in use and possibly providing more informationfor the user and/or user monitoring.

This objective is achieved by a nebulizer according to claim 1.Advantageous features are recited in the subsidiary claims.

According to a first aspect of the present invention, the monitoringdevice is mounted on a detachable housing part of the nebulizer,particularly fixedly connected thereto, preferably cast therein. Thisallows the monitoring device, together with the housing part, to beremoved easily from the nebulizer so that the monitoring device can veryeasily be switched on, programmed, started up, and/or read off,separately or independently of the nebulizer, and/or so that the entiremonitoring device, together with the housing part, can be changed or anebulizer can be fitted with a monitoring device if the housing part iscompatible.

Another aspect of the present invention, which can also be realizedindependently, consists of detecting the actual dispensing of fluid and,in particular, counting it electronically as an actuation of thenebulizer. This results in improved monitoring and better safety of useand guidance for the user.

Actual dispensing is preferably detected by directly detecting movement,preferably actuation, of the container by means of a receiving sensordetecting an air supply current produced by inhalation and/or a spraysensor detecting the production of nebulized fluid or aerosol,particularly in the region of a mouthpiece. Accordingly, it is possibleto determine with substantially greater certainty whether the dispensingof fluid has actually taken place or inhalation as actually occurred.Preferably, the monitoring is carried out not only qualitatively, butalso quantitatively.

According to an alternative embodiment, the monitoring device detectsand, in particular, records, by means of the receiving sensor,sufficiently strong and/or long lasting inhalation of the fluidnebulized by the nebulizer, and/or counts it as a (successful) actuationof the nebulizer or intake of fluid. This contributes to safer operationand improved monitoring.

Most preferably, the monitoring device of the nebulizer is provided witha timer and a memory so that the number and time of the actuations ofthe nebulizer can be detected and recorded, and/or repeated actuationwithin a given minimum period can be blocked, and/or so that a remindersignal preferably for a repeat application can be emitted or displayed,preferably after a given maximum period has elapsed.

When the number and times of the actual dispensing of fluid are detectedand recorded, continuous monitoring is possible, e.g., by the doctor orin clinical trials. By consulting the monitoring device or memory, it isthus possible to detect when the liquid was administered and possiblywhat quantities were dispensed by the nebulizer.

Blocking of repeated actuation of the nebulizer within a predetermined,preferably adjustable and recordable minimum period, can preventoverdosing of the fluid, which is preferably a highly effectivepharmaceutical composition.

By emitting a reminder signal, preferably for repeat actuation of thenebulizer after a predetermined, preferably adjustable and recordablemaximum period has expired, a user can be reminded that a freshinhalation is required. Thus, regular inhalation, i.e., administrationof the fluid, can be assisted. In particular, the reminder signal canindicate the time until the next inhalation or actuation, or possiblyoverdue inhalation or actuation. The reminder signal is most preferablya warning or alarm signal, particularly as disclosed in WO 03/092576,the entirety of which are hereby incorporated by reference.

DESCRIPTION OF THE DRAWINGS

Further advantages, features, properties, and aspects of the presentinvention will become apparent from the following description ofpreferred embodiments referring to the drawings, wherein:

FIG. 1 is a diagrammatic section through a known nebulizer in theuntensioned state;

FIG. 2 shows a diagrammatic section through the known nebulizer in thetensioned state, rotated through 90° compared with FIG. 1;

FIG. 3 is a diagrammatic sectional view of a lower housing part of aproposed nebulizer with integral monitoring device;

FIG. 4 is a block circuit diagram of the monitoring device;

FIG. 5 is a diagrammatic representation of a connecting device for themonitoring device; and

FIG. 6 is a diagrammatic section through another proposed nebulizer witha receiving sensor and a spray sensor.

In the Figures, identical reference numerals are used for identical orsimilar parts, and corresponding or comparable properties and advantagesare achieved even if the description is not repeated.

DESCRIPTION OF THE INVENTION

FIGS. 1 and 2 show a known nebulizer 1 for nebulizing a fluid 2,particularly a highly effective pharmaceutical composition or the like,viewed diagrammatically in the untensioned state (FIG. 1) and in thetensioned state (FIG. 2). The nebulizer is constructed in particular asa portable inhaler and preferably operates without propellant gas.

When the fluid 2, preferably a liquid, more particularly apharmaceutical composition, is nebulized, an aerosol is formed that canbe breathed in or inhaled by a user (not shown). Usually the inhaling isdone at least once a day, more particularly several times a day,preferably at set intervals.

The nebulizer 1 has an insertable and preferably exchangeable container3 containing the fluid 2, which forms a reservoir for the fluid 2 thatis to be nebulized. Preferably, the container 3 contains an amount offluid 2 sufficient for multiple use, particularly for a given period ofadministration, such as one month, or for at least 50, preferably atleast 100, doses or sprays.

The container 3 is substantially cylindrical or cartridge-shaped and,once the nebulizer 1 has been opened, the container can be insertedtherein from below and changed if desired. It is preferably of rigidconstruction, the fluid 2, in particular, being held in a bag 4 in thecontainer 3.

The nebulizer 1 has a pressure generator 5 for conveying and nebulizingthe fluid 2, particularly in a preset and optionally adjustable dosageamount. The pressure generator 5 has a holder 6 for the container 3, anassociated drive spring 7 with a locking element 8 that can be manuallyoperated to release it, a conveying tube 9 with a non-return valve 10, apressure chamber 11, and an expulsion nozzle 12.

As the drive spring 7 is axially tensioned, the holder 6 with thecontainer 3 and the conveying tube 9 are moved downwards in thedrawings, and fluid 2 is sucked out of the container 3 into the pressurechamber 11 of the pressure generator 5 through the non-return valve 10.As the expulsion nozzle 12 has a very small cross section of flow and isconstructed, in particular, as a capillary, such a strong throttleaction is produced that the intake of air by suction is reliablyprevented at this point even without a non-return valve.

During the subsequent relaxation, after actuation of the locking element8, the fluid 2 in the pressure chamber 11 is put under pressure by thedrive spring 7 moving the conveying tube 9 back upwards, i.e., by springforce, and is expelled through the expulsion nozzle 12 where it isnebulized, particularly in particles in the μm or nm range, preferablyparticles destined for the lungs measuring about 5 μm. The conveying andnebulizing of the fluid 2 are thus carried out purely mechanically, inparticular, without propellant gas and without electricity.

The nebulizer 1 comprises an upper housing part 13 and an inner part 14which is rotatable relative thereto, on which an actuating member 15 isreleasably fixed, particularly fitted on, preferably by means of aretaining element 16. In order to insert and/or replace the container 3,the actuating member 15 can be detached from the nebulizer 1.

By manually rotating the actuating member 15, the inner part 16 can berotated relative to the upper housing part 13, as a result of which thedrive spring 7 can be tensioned in the axial direction by means of agear (not shown) acting on the holder 6. During tensioning, thecontainer 3 is moved axially downwards until the container 3 assumes anend position as shown in FIG. 2 in the tensioned state. During thenebulizing process, the container 3 is moved back into its originalposition by the drive spring 7. The axial movement of the container 3during actuation of the nebulizer 1 is hereinafter referred to as thestroke of the container 3.

The housing part 15 preferably forms a cap-like lower housing part andfits around or over a lower free end portion of the container 3. As thedrive spring 7 is tensioned, the container 3 moves with its end portion(further) into the actuating member 15 or towards the end face thereof,while an axially acting spring 17 arranged in the actuating member 15comes to bear on the base 18 of the container, and pierces the container3 with a piercing element 19, when the container makes contact with itfor the first time, to allow air in.

The nebulizer 1 comprises a monitoring device 20 that counts theactuations of the nebulizer 1 by detecting any rotation of the innerpart 14 relative to the upper part 13 of the housing. The monitoringdevice 20 operates purely mechanically.

The construction and mode of operation of a proposed nebulizer 1 with amodified monitoring device 20 will now be described in more detail,referring to the sectional view in FIG. 3 and the block circuit diagramin FIG. 4, and otherwise the remarks relating to FIGS. 1 and 2 apply.

The monitoring device 20 is preferably incorporated in a detachable, andpreferably, exchangeable housing part of the nebulizer 1, particularlyin the actuating member 15 of the nebulizer 1. The monitoring device 20is preferably mounted, more particularly cast, in the region of theaxial end of the nebulizer 1 or of the actuating member 15.

When the container 3 is inserted, the monitoring device 20 is preferablyarranged adjacent to the container base 18 of the container 3 and/or onan extension of the direction of movement or travel of the container 3.

The monitoring device 20 detects, as the actual dispensing of fluid 2,preferably, movements or strokes of the container 3, preferably bymechanical, optical, electrical, inductive, capacitive, and/or otherwisecontactless means. In particular, the monitoring device 20, according tothe embodiment shown, comprises a microswitch 21 or other switch, e.g.,a proximity switch, inductive switch, capacitive switch, or reedcontact, or a suitable sensor.

The microswitch 21 specifically provided here can be operated by aprojection 22 of the spring 17. In particular, in its lower endposition, i.e., with the nebulizer 1 or pressure generator 5 undertension, the container 3 depresses the spring 17 so that the projection22 actuates the microswitch 21.

In the embodiment shown, the movements or strokes of the container 3extend in an axial or linear manner. However, the monitoring device 20can also or alternatively detect a non-linear or non-axial movement ofthe container 3 in a different construction of nebulizer 1 and/or amovement of some other part of the nebulizer 1, particularly when it isactuated. For example, the monitoring device 20 may alternatively oradditionally detect actuation of the nebulizer 1 or the actualdispensing of fluid 2 by measuring the impedance of the spring 17, whichvaries as a function of the tensioning position.

The monitoring device 20 preferably detects, when the container 3reaches the end position in the tensioned state and/or when it leavesthis position during the nebulizing process, as an actuation of thenebulizer 1 that is counted. In particular, the monitoring device 20comprises a control unit 23, preferably a microcontroller or the like,for carrying out the above mentioned counting and/or other functions ofthe monitoring device 20. The other components of the monitoring device20 are connected to the control unit 23.

Alternatively or additionally, the monitoring device 20 can also detectmovements of the container 3 or some other part of the nebulizer 1, suchas the spring 17 or holder 6, and, in particular, evaluate them.Preferably, the position, speed, the associated parameters, and,especially, a distance/time curve, or the like, are detected andevaluated.

In addition, the monitoring device 20, when counting, also detects thetime of actuation, which will be discussed in more detail hereinafter.

The strokes of the container 3 thus constitute a numerical value for thenumber of actuations of the nebulizer 1 and hence for the quantity offluid 2 dispensed. The numerical value also indicates the fill level ofthe fluid 2.

Preferably, the numerical value of the actuations of the nebulizer 1 canbe manually or automatically reset, particularly when changing thecontainer 3; the number of actuations that has occurred and/or thenumber of possible actuations with the current container 3 being capableof being displayed and/or stored as desired. Preferably, the resettingof the numerical value takes place automatically after the fitting orpushing on of the actuating member 15, the fitting or putting on of theactuating member 15 preferably being detectable by the monitoring device20 by means of a contact switch 24 or the like.

In the embodiment shown, the contact switch 24 can be initiated oractuated by means of a spring-loaded contact pin, the contact pin beingpressed down or inwards against spring force by the inner part 14 whenthe actuating member 15 is fitted on. In addition to the automaticresetting of the numerical value, this embodiment has the furtheradvantage that once the nebulizer 1 has been put together it isimpossible for the contact switch 24 to be (re-)actuated and thenumerical value thereby reset. This results in simple operation of thenebulizer 1 that is not susceptible to operating errors.

The contact switch 24 may additionally or alternatively serve to switchon or activate the monitoring device 20, particularly by detecting theassembly of the nebulizer 1 for the first time.

Alternatively or in addition to the contact switch 24, some otherswitch, such as an inductive switch, capacitive switch, reed contact,proximity switch, or the like, or any other suitable sensor, may beused.

According to an alternative embodiment, the nebulizer 1 is preferablyconstructed so that it can only be initiated or actuated when themonitoring device 20 is installed or added on and/or when the monitoringdevice 20 is switched on. This can be achieved by a suitable mechanicaland/or electrical connection or coupling of the nebulizer 1 to themonitoring device 20 or optionally to the housing part or actuatingmember 15 containing the monitoring device 20.

In particular, the nebulizer 1 is prevented from being actuated if themonitoring device 20 is not switched on, if there is no monitoringdevice 20, if there is no actuating member 15, and/or if there is nocontainer 3.

The monitoring device 20 preferably has, in particular, an opticalindicator device 25, which may be, as in the embodiment shown, a displayor the like, particularly for indicating the status of the monitoringdevice 20, the time that has elapsed since the last actuation of thenebulizer 1, the time remaining until the next actuation of thenebulizer 1, the number of actuations of the nebulizer 1 that havealready occurred, the number of actuations of the nebulizer 1 that arestill possible, the number of actuations of the nebulizer 1 that stillhave to be carried out (e.g., when inserting a new container 3),indicating whether the container has been changed or has to be changed,the fill level of fluid, identification of the container, and/ordesignation of the fluid. This provides optimum information and possibleguidance for the user. Thus the handling of the nebulizer 1 is madeeasier and greater operational safety is provided.

The monitoring device 20 preferably has an acoustic indicator device 26,particularly a peso electric signal transmitter or the like,particularly for emitting a reminder signal for reminding the user thatactuation of the nebulizer 1 is due and/or for indicating an ongoingand/or completed nebulizing process.

For example, by emitting an audible signal that lasts throughout theatomizing process, the monitoring device 20 can tell the user thatnebulization has occurred and the user should inhale the aerosol formedaccordingly. Preferably, the audible signal does not end as thenebulizing process ends, but only after a period extending beyond thatto ensure that the user has inhaled all the aerosol produced. In view ofthe comparatively accurate period of about one to two seconds for thenebulizing process, the total duration of the audible signal may be laiddown irrespective of the actual atomising process by a preferablypredetermined time of, for example, three to four seconds, or about 10to 15 seconds, if allowance is made for a desirable period of holdingones breathe after inhaling. The monitoring device 20 then emits theaudible signal after the initiation of the nebulizing process byactuating the locking element 8, i.e., starting with the detection ofthe stroke of the container 3 in the direction of nebulizing by means ofthe microswitch 21.

Alternatively or in addition to the above mentioned audible signal thatis emitted continuously or repeatedly during the actual nebulizingprocess or the nebulizing process to be displayed, the monitoring device20 may also emit an end signal to indicate the end of the atomisingprocess, e.g., after the predetermined time has elapsed.

In addition or alternatively, a user may be informed, by means of theacoustic indicator device 26, possibly with another signal, of theactual duration of inhaling and/or whether the inhaling was powerfulenough and/or whether the inhalation was not powerful enough or did notlast long enough.

Preferably, the acoustic indicator device 26 generates a sound signalthat may if necessary emerge through an opening provided in theactuating member 15.

Additionally or alternatively, the acoustic indicator device 26 maycause vibration of the actuating member 15 or nebulizer 1 as a signal,i.e., it may emit a vibrating signal or a signal which is otherwisetactile.

The monitoring device 20 comprises an energy store, particularly abattery 27 or, optionally, an accumulator. The energy store ispreferably only connected once the monitoring device 20 has beenswitched on, to allow a long shelf life with minimum loss of energy.

Preferably, the energy store or battery 27 has a capacity such that themonitoring device will remain operational for at least one year,preferably at least two years, and, in particular, at least five yearsafter being switched on.

The monitoring device 20 also comprises an interface 28, which ispreferably a light emitting diode, that preferably operates onlyoptically, and that allows the monitoring device 20 in particular to beswitched on, programmed, set, reset, and/or interrogated.

In order to communicate with the monitoring device 20 via the interface28, a connecting device 29, shown, by way of example, in FIG. 5, ispreferably provided. In particular, the monitoring device 20 isconnectable to the connecting device 29 through the interface28—optionally only after the monitoring device 20, together with thehousing or actuating member 15, has been disconnected from the nebulizer1. Preferably, the connecting device 29 comprises a light emitting diode30 or the like for preferably optical communication or data transmissionwith the monitoring device 20.

In order to connect it up, the monitoring device 20 or actuating member15 is adapted to be inserted in a suitable recess 31 in the connectingdevice 29, in particular, and/or the connecting device 29 can be atleast partially inserted in the actuating member 15.

The connecting device 29 is preferably connectable to a computer or thelike, e.g., through a connection 32. Accordingly, the monitoring device20 is very easy to initiate, switch on, program, reset, interrogate, andthe like. Data stored by the monitoring device 20 is accordingly easy tocall up, display, and optionally evaluate. This is particularlyadvantageous for clinical trials and/or the monitoring of a patient by adoctor.

Alternatively or in addition, the connecting device 29 may also besuitable for use independently of a computer or the like.

If necessary, the connecting device 29 may also have its own displayand/or a keyboard or other input device for switching on, programming,setting up, resetting, and/or interrogating the monitoring device 20. Inparticular, various parameters or the like can then be displayed and, inthis case, the optical display device 25 and/or an input device 35 ofthe monitoring device 20 may be omitted if desired.

Instead of the battery 27, an accumulator may be used if desired. Thiscan be charged up, for example, through an electrical connection or,possibly, inductively, especially at the same time as it is connected tothe connecting device 29 and/or through a solar cell of the monitoringdevice 20.

The monitoring 20 is preferably constructed so that it is only switchedon when first fitted together with the nebulizer 1, when the container 3is first inserted, when the pressure generator 5 is first tensioned oractuated, and/or when it is initiated through the interface 28. This isadvantageous in terms of a long shelf life.

Preferably, the monitoring device 20 cannot be switched off once it hasbeen switched on. This ensures the desired continuous monitoring.

The monitoring device 20 preferably comprises a timer 33 and a memory34, particularly so that the number and times of actuation of thenebulizer 1 or the dispensing of fluid 2 can be detected and stored,and/or so that repeated actuation of the nebulizer 1 within a givenminimum period is preventable, and/or so that once a predeterminedmaximum time has elapsed the reminder signal mentioned previously forrepeated actuation of the nebulizer 1 can be emitted.

When the number and times of the actuations or dispensing of fluid 2 arerecorded continuously in the memory 34, it is possible, by interrogatingthe monitoring device 20, i.e., by reading the memory 34, to check andmonitor when and to what extent the nebulizer 1 has been used or fluid 2has been dispensed. The monitoring option is beneficial for the user forself-monitoring and/or for monitoring by the treating doctor and/or forclinical trials, particularly to check that the prescribed doses offluid 2 are being taken.

If repeated actuation of the nebulizer 1 within a given minimum periodis preventable, overdosing can be prevented.

The memory 34 preferably has an EPROM or EEPROM, while in the lattercase electrical resetting is possible.

The memory 34 or its contents can preferably not be erased or altered atleast by the user or patient.

Preferably, the timer 33 does not constitute an absolute time base;rather, it is a (simple) counter that only measures or provides relativetime. This results in a particularly simple and inexpensive structure.

The absolute start of the resolute time measurement by the timer 33 ispreferably laid down on initiating or first switching on the monitoringdevice 20 and is stored, in particular, in the memory 34 or by someother device, such as a computer for initiating the monitoring device20.

Alternatively or additionally, the absolute end of the relative timemeasurement by the timer 33 can easily be laid down by interrogating themonitoring device 20 by comparison with an absolute time base. Thus, theabsolute times of the actuations of the nebulizer 1 detected by themonitoring device 20 and stored in the memory 34 can be laid down ordetermined.

According to a preferred alternative embodiment, the nebulizer 1 and/orthe monitoring device 20 is or are constructed so that the container 3uses, and/or its fill level, and/or its fluid 2 can be preferably,automatically identified by the monitoring device 20 and theidentification of the container can, in particular, be stored and/orindicated or displayed. In this way, it is possible to tell whichcontainer 3, and hence which fluid 2, has been used.

For example, the monitoring device 20 or the nebulizer 1 may comprise abar code reader or other means for interrogating identification orcoding, such as a bar code, on the container 3. Thus, it is possible totell whether the wrong container 3, or a container 3 containing thewrong fluid 2, the wrong amount of fluid, and/or the wrong concentrationof active substance in the fluid 2, has been used. Depending on theprogramming or setting of the monitoring device 20, it is then possibleto block actuation of the nebulizer 1.

The monitoring device 20 preferably comprises an identifier, capable ofbeing interrogated, for identifying the monitoring device 20, thenebulizer 1, and/or a user.

The monitoring device 20 preferably comprises, alternatively oradditionally to the interface 28, a manually actuated input device 35,particularly a key, keyboard, or the like. Preferably, the monitoringdevice 20 can be switched on, programmed, set, reset, and/orinterrogated using the input device 35. For example, using the inputdevice 35, it is possible to input the minimum time, maximum time,and/or number of doses, e.g., the number of actuations per use and thenumber of uses per day.

All or at least most of the components of the monitoring device 20 arepreferably mounted on a printed circuit board 36 and/or attachedthereto. In particular, the monitoring device 20 forms an assembly thatis inserted, preferably cast, into the housing or actuating member 15 ofthe nebulizer 1.

According to another aspect, which may, if necessary, be implementedindependently, the proposed nebulizer 1 comprises a receiving sensor 38,particularly in the region of a mouthpiece 37 or expulsion nozzle 12,for detecting an air current and/or the inhaling or nebulized fluid 2,as shown in FIG. 6.

Preferably, an air supply opening 39 is associated with the receivingsensor 38, through which an air supply can be sucked in by a user oninhalation, particularly laterally or in the region of the expulsionnozzle 12, as indicated by arrows in FIG. 6.

According to a first alternative embodiment, the receiving sensor 38 ispreferably constructed directly in order to detect a corresponding airsupply current, so that inhalation of the aerosol 40, asdiagrammatically indicated in FIG. 6, can be detected.

Preferably, the receiving sensor 38 is able to detect the direction ofan air flow through the air supply opening 39, the flow velocity, and/orthe flow volume. For this purpose, the receiving sensor 38 may, forexample, be constructed as a so-called “flow sensor” for directlydetecting an air flow, or it may have an associated, preferably freely,pivoting flap, a flywheel that can be rotated by the air current, or thelike.

According to a particularly preferred second alternative embodiment,which can also be implemented independently, if necessary, a valve 41,as diagrammatically shown in FIG. 6, and constructed, in particular, asa one-way or non-return valve, preferably having a movable valve element42, is associated with the air supply opening or openings 39 to prevent(accidental) expulsion of the aerosol 40 through the air supplyopening(s) 39. In this case the receiving sensor 38 preferably, directlydetects only the opening and/or closing of the valve 41, i.e., itdetects the air supply current only indirectly. This gives rise to aparticularly simple and inexpensive construction, especially when thereceiving sensor 38 comprises a microswitch, for example, that can beactuated by the valve element 42.

The receiving sensor 38 is preferably connected to the monitoring device20 that evaluates the signals of the receiving sensor 38 accordingly andstores them in particular. This can be done, if necessary, without wiresor even mechanically. Preferably, the receiving sensor 38 iselectrically connected to the monitoring device 20 by leads and suitablecontacts at the transition to the actuating member 15.

By means of the receiving sensor 38, the air supply current, and hencethe actual inhaling of the aerosol 40 produced using the nebulizer 1,can be detected. Accordingly, alternatively, or in addition to detectingthe movement of the container 3, the monitoring device 20 is able tocount inhalation of the aerosol 40 detected by the receiving sensor 38as an actual dispensing or uptake of the fluid 2 or (successful)actuation of the nebulizer 1 and process, display, store, etc., thisnumerical value in the manner described previously.

The detection of actual inhalation of the fluid 2, which is possibleusing the receiving sensor 38, can be evaluated by the monitoring device20 to say whether inhalation was long enough, while the inhalation timemay, if necessary, be stored and/or displayed.

According to another embodiment, the nebulizer 1 comprises, in additionor alternatively to the receiving sensor 38, a spray sensor 43 that canbe used to detect whether nebulization has actually occurred. Inparticular, the spray sensor detects whether droplets of the nebulizedfluid 2 or aerosol 40 have actually formed in the region of themouthpiece 37. For example, the sensor makes use of the effect of lightbeing scattered by the nebulized fluid 2 or aerosol 40 and operates as aso-called “scattered light sensor. ”

The spray sensor 43 can also detect whether nebulization has actuallyoccurred. In particular, the monitoring device 20 checks whether, onactuation of the nebulizer 1, preferably within a predetermined timewindow, nebulization is actually detected by means of the abovementioned sensor, and, only if actual nebulization is detected, is theactuation of the nebulizer 1 actually detected or counted as thedispensing of fluid 2 and hence as a nebulizing process.

Alternatively or in addition to detecting a movement of the container 3or any other component, the monitoring device 20 is able to detect anair supply current by means of the receiving sensor 38 and/or can detectthe production of an aerosol 40 by means of the spray sensor 43 andevaluate them, optionally only when they occur cumulatively, as anactual dispensing of fluid 2, and count them as an actuation of thenebulizer 1, and optionally store them, particularly together with thetime at which they occurred.

1. A nebulizer for a fluid comprising: an insertable or exchangeable container containing the fluid, a pressure generator for conveying and/or nebulizing the fluid, and a monitoring device for counting actuations of the nebulizer, wherein the monitoring device is adapted so that actual dispensing of fluid can be detected and counted electronically as an actuation of the nebulizer
 2. The nebulizer of claim 1, wherein the monitoring device comprises a timer and a memory so that the number and times of the actuations of the nebulizer can be detected and stored, or so that repeated actuation of the nebulizer within a predetermined minimum period of time can be blocked, or so that a reminder signal for fresh actuation of the nebulizer can be emitted or displayed after a predetermined maximum length of time has elapsed.
 3. The nebulizer according to claim 2, wherein the timer measures only relative time.
 4. The nebulizer according to claim 3, wherein the absolute start of the relative time measurement by the timer can be recorded on start-up or when the monitoring device is first switched on, and wherein


5. The nebulizer according to claim 3, wherein the absolute end of the relative time measurement by the timer can be fixed on interrogation of the monitoring device by comparison with an absolute time base.
 6. The nebulizer according to claim 1, wherein the nebulizer further comprises an actuating member that is releasable or replaceable for the insertion of the container, and wherein the monitoring device is mounted on the actuating member or incorporated in the actuating member.
 7. The nebulizer according to claim 1, wherein the container is axially movable when the nebulizer is actuated, and wherein the monitoring device directly detects movement of the container and evaluates or counts the movement as the dispensing of fluid.
 8. The nebulizer according to claim 7, wherein the monitoring device detects movements of the container by mechanical, optical, electrical, inductive, capacitive, or other contactless means.
 9. The nebulizer according to claim 7, wherein the monitoring device comprises a microswitch or sensor for detecting movements of the container.
 10. The nebulizer according to claim 9, wherein the microswitch or sensor is operable by the container by means of a spring.
 11. The nebulizer according to claim 1, wherein the monitoring device is adapted to detect or evaluate movements of the container during tensioning or actuation of the pressure generator or during the conveying or nebulizing of the fluid.
 12. The nebulizer according to claim 11, wherein the monitoring device detects the container arriving at or leaving an end position in which the pressure generator is tensioned.
 13. The nebulizer according to claim 1, wherein the monitoring device counts, displays, or indicates the actuations of the nebulizer that have already taken place or are still possible with the container, and wherein the monitoring device can be reset manually or automatically as the container is changed by means of a contact switch, and wherein resetting the monitoring device is prevented once the nebulizer is assembled.
 14. The nebulizer according to claim 1, wherein the monitoring device comprises an optical indicator device for indicating information selected from the group consisting of: the time that has elapsed since the last actuation of the nebulizer, the time remaining until the next actuation of the nebulizer, the number of actuations of the nebulizer that have already occurred, the number of actuations of the nebulizer that are still possible, actuations of the nebulizer that are still to be carried out, the fact that the container has been changed or needs to be changed, the fluid level, identification of the container, the designation of the fluid, and combinations thereof.
 15. The nebulizer according to claim 1, wherein the monitoring device comprises an acoustic indicator device for emitting a reminder signal for actuating the nebulizer, or for indicating an ongoing or completed nebulizing process.
 16. The nebulizer according to claim 15, wherein the acoustic indicator device is a piezoelectric signal transmitter.
 17. The nebulizer according to claim 1, wherein the monitoring device comprises an energy store, and wherein the energy store has a capacity such that the monitoring device remains operational for at least one year after being switched on.
 18. The nebulizer according to claim 1, wherein the monitoring device comprises a purely optical interface for switching on, initialising, programming, setting, resetting, and interrogating the monitoring device.
 19. The nebulizer according to claim 18, wherein the optical interface is a light-emitting diode.
 20. The nebulizer according to claim 1, wherein the monitoring device comprises an interrogatable identifier for identifying the monitoring device, the nebulizer, or a user.
 21. The nebulizer according to claim 1, wherein the nebulizer or the monitoring device is constructed such that the container used can be identified by the monitoring device, and wherein the container identification can be stored in the memory.
 22. The nebulizer according to claim 1, wherein the nebulizer comprises a receiving sensor for detecting an air supply current, and wherein signals from the receiving sensor can be detected by the monitoring device.
 23. The nebulizer according to claim 22, wherein the monitoring device evaluates the signals from the receiving sensor in terms of a sufficient strength or sufficient duration of inhalation, and stores, displays, or counts these signals as a successful inhalation of fluid or as the actual dispensing of fluid.
 24. The nebulizer according to claim 23, wherein the receiving sensor is associated with an air supply opening in the nebulizer.
 25. The nebulizer according to claim 24, wherein a valve is associated with the air supply opening and the receiving sensor detects movement of a valve element of the valve.
 26. The nebulizer according to claim 22, wherein the receiving sensor is constructed as a flow sensor for detecting a direction of flow, the flow velocity, flow volume, or mass flow.
 27. The nebulizer according to claim 1, wherein the nebulizer comprises a spray sensor for detecting whether, on actuation of the nebulizer, nebulized fluid or an aerosol is actually being produced or expelled.
 28. The nebulizer according to claim 27, wherein the spray sensor operates as a scattered light sensor.
 29. The nebulizer according to claim 27, wherein the monitoring device counts the production of nebulized fluid or aerosol detected by the spray sensor as being an actual dispensing of fluid.
 30. The nebulizer according to claim 27, wherein the monitoring device only counts an actuation of the nebulizer as an actual dispensing of fluid when the production of nebulized fluid or aerosol is detected by the spray sensor. 